Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Intravaskulær ultralydveiledet intervensjon for venøse bensår (IGuideU) (IGuideU)

2. november 2026 oppdatert av: Philips Clinical & Medical Affairs Global

Intravaskulær ultralydveiledet intervensjon for venøse bensår

This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will result in a more accurate diagnosis of deep vein occlusion (DVO), will guide optimal therapy, and will provide better clinical outcomes with reduced cost of care for patients presenting with persistent venous leg ulcers (VLUs).

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This study will be conducted in 266 subjects presenting with venous ulcers that have previously undergone treatment for superficial of and/or perforator venous disease, if clinically indicated, followed by at least 3 months of prescribed compression therapy prior to screening.

There are 6 study visits for each subject that will be completed over a period lasting approximately 24 months. Subjects will undergo a baseline/screening assessment (visit 1) followed by an interrogation procedure (visit 2) if the subject is enrolled into the interrogation arm. If the subject is randomized to the deferred interrogation arm, he/she will have a hospital/office visit in lieu of the interrogation procedure, which will be considered visit 2. For statistical purposes, the wound assessment performed at the index procedure/hospital visit will be considered the baseline measurement. 30±14 days and 90±14 days after Visit 2, the subject will return to the office for a 1- and 3-month follow-up visit, respectively. The subjects will return at 6- and 12-months post-index procedure/Visit 2 for follow-up assessments. The follow-up period for this study will be approximately 24 months, with a phone call only at 24-months post-index procedure/visit 2.

The clinical study has a planned enrollment period of 36 months and a planned study duration period of 5.17 years

Studietype

Intervensjonell

Registrering (Faktiske)

12

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia, 2500
        • Wollongong Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Forente stater
    • Connecticut
      • Darien, Connecticut, Forente stater, 06820
        • Vascular Care Connecticut
    • Florida
      • Winter Park, Florida, Forente stater, 32792
        • Florida Cardiology, P.A.
    • Illinois
      • Chicago, Illinois, Forente stater, 60208
        • Northwestern
    • Louisiana
      • Houma, Louisiana, Forente stater, 70394
        • Cardiovascular Institute of the South
      • Lake Charles, Louisiana, Forente stater, 70601
        • Vein Center of Southwest Louisiana
    • New Jersey
      • Englewood, New Jersey, Forente stater, 07631
        • Englewood Hospital and Medical Center
    • New York
      • New York, New York, Forente stater, 10016
        • NYU Langone Health
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28210
        • Atrium Health
  • Frankrike
      • Dijon, Frankrike, 77908
        • C.H.U. Dijon
    • Alsace
      • Strasbourg, Alsace, Frankrike, 67000
        • CHU Strasbourg
    • Bourbonnais
      • Vichy, Bourbonnais, Frankrike, 03200
        • CH Vichy
  • Storbritannia
      • Hampstead, Storbritannia
        • Royal Free London NHS Foundation Trust
      • London, Storbritannia
        • Guys and St. Thomas' Hospital
    • London
      • Harrow, London, Storbritannia, HA1 3UJ
        • Northwick Park Hospital
  • Tyskland
    • North Rhine-Westphalia
      • Arnsberg, North Rhine-Westphalia, Tyskland, 59755
        • Klinikum Hochsauerland GmbH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Be between 18 and 85 years of age.
  • Able and willing to participate and comply with the protocol, including the defined follow-up schedule, by signing an Institutional Review Board (IRB) or Ethics Committee approved informed consent form.
  • Active venous leg ulcer (CEAP C6).
  • Previously completed treatment for clinically significant reflux in the superficial and/or perforator venous system of the target limb at least 3 months prior to enrollment, if clinically indicated.
  • Completed at least 3 months of prescribed compression therapy after any ablation.
  • Palpable dorsalis pedis or posterior tibial artery (DP/PT) pulses at ipsilateral foot or ankle brachial index (ABI) ≥0.8.
  • Be able to ambulate unassisted or with non-motorized assistive devices.
  • Current VLU present ≤48 months.

Exclusion Criteria:

  • Patient is known pregnant or breast-feeding or planning to become pregnant in the following year.
  • If antiplatelet and anticoagulation therapy cannot be tolerated.
  • Previous venous stent implantation involving the target limb, target lesion, or inferior vena cava.
  • Previous venovenous bypass surgery involving the target limb.
  • Previous endovascular recanalization of the target lesion segment.
  • Known metal allergy precluding stent implantation.
  • Known or suspected to have inadequate inflow to support stent patency in the target limb.
  • Active cancer diagnosis.
  • Known positive test for COVID-19 (Sars-CoV-2) within the last 2 weeks and actively symptomatic.
  • Known or suspected venous outflow obstruction caused by tumor compression/encasement with or without thrombus.
  • Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
  • Known renal dysfunction (defined as eGFR <30mL/min/1.73m2) that would preclude adequate contrast usage.
  • Diagnosed with right heart failure/pulmonary hypertension.
  • Has known clinically significant abnormal platelet count outside laboratory reference ranges.
  • Has known clinically significant abnormal white blood cell count (WBC), fever, sepsis or positive blood culture.
  • Organ transplant requiring immunosuppressant therapy.
  • Unstable angina pectoris, or myocardial infarction within 30 days and/or hemorrhagic stroke within 3 months.
  • Subjects with an active diagnosis of osteomyelitis of the ipsilateral limb.
  • Previous or planned surgical or catheter-based procedure on index leg within 30 days before or 30 days after the index procedure.
  • Active participation in another investigational drug or device study.
  • Subject has any condition, which, in the opinion of the investigator, precludes the subject from participation.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Interrogation Arm

patients will first be evaluated with MPV (limited to 3 views). The prescribed course of treatment based on the MPV results will be documented and patients will then be evaluated using IVUS. A treatment plan based on IVUS results will be compared with the MPV guided treatment plan and any differences will be documented. Any patients determined to still require venous stenting based on IVUS results will be stented accordingly using IVUS to guide stent placement.
Diagnostisk test: IVUS

Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.
Annen: Deferred Interrogation Arm

Deferred Interrogation Guidelines for this study are as follows:

Mandate:

• Continued compression therapy/stockings as prescribed.

Allow:

  • Periodic leg elevation.
  • Sclerotherapy under ulcer bed.
  • Recommend mechanical debridement as needed.
  • Wound biopsy if evidence of infection.
  • Systemic antibiotics if patient is diagnosed with an infection, avoid prophylactic prescription.
  • Pain management medication (Pentoxifylline/Trental) allowed but not recommended
  • Topical antimicrobial as needed.

Prohibit:

  • Negative pressure systems.
  • Artificial and/or autologous skin grafting within first 3 months after randomization and within the first 3 months for subjects that crossover from deferred interrogation to the interrogation arm.
Annen: Continued Compression Therapy/Stockings

Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of Detection and Difference in Complete Ulcer Healing Between the Interrogation Group and the Deferred Interrogation Group
Tidsramme: 3 months

Rate of detection and difference in complete ulcer healing between the interrogation group and the deferred interrogation group at 3 months. Complete ulcer healing is defined by 100% epithelialization of the venous ulcer. Healing will not be assumed for any area of the wound where a scab is present.
3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Philips Clinical & Medical Affairs Global

Etterforskere

  • Hovedetterforsker: Stephen Black, MD, St. Thomas and Guys Hospital
  • Hovedetterforsker: Paul Gagne, MD, Vascular Care CT, PLLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. oktober 2021

Primær fullføring (Faktiske)

11. januar 2023

Studiet fullført (Faktiske)

17. januar 2023

Datoer for studieregistrering

Først innsendt

14. desember 2020

Først innsendt som oppfylte QC-kriteriene

4. januar 2021

Først lagt ut (Faktiske)

6. januar 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IGT_IGD_VLU_2020_10876
  • 200202 (Annen identifikator: IGTD Protocol no.)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere